A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals (RSCMI-I)

C

China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Ischemic Stroke

Study type

Observational

Funder types

Other

Identifiers

NCT01508403
2009zx09502-030

Details and patient eligibility

About

The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Full description

This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China. It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system. However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report. In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area. To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. According to the 'rule of three', 30,000 cases need to be registered at least.

Enrollment

30,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay

Trial design

30,000 participants in 1 patient group

Shuxuetong injection
Description:
a cohort using Shuxuetong injection

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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